Congenital Heart Disease in ChildrenNCT06373705
Cardiac Simulator for Surgical Planning
A study testing Cardiac simulator in people with Congenital Heart Disease in Children, run by Stanford University.
Trial summary
The goal of this clinical trial is to learn if a computer software program (cardiac simulator) for surgical planning will lead to improvements in patient care by decreasing the incidence of unsuccessful interventions and reinterventions for pediatric patients with congenital heart disease. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Congenital Heart Disease in Children
- What is being tested?
- Cardiac simulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The inclusion criteria are pediatric patients ages 0-17 with a congenital heart disease (CHD) diagnosis of 1) congenitally corrected transposition of the great arteries (cc-TGA) with ventricular septal defect (VSD), 2) double outlet right ventricle (DORV) with remote VSD, or 3) other single ventricle conditions.
Who cannot join
- Adult patients with CHD.
About this study
Official title: Utilizing a Multi-Physics Cardiac Simulator for Surgical Planning in Complex Congenital Heart Disease Pediatric Patients
The goal of this clinical trial is to learn if a computer software program (cardiac simulator) for surgical planning will lead to improvements in patient care by decreasing the incidence of unsuccessful interventions and reinterventions for pediatric patients with congenital heart disease. It is not a commercially available device to treat congenital heart disease in pediatric patients. The main aims are:
To provide safe pre-operative testing of surgical approaches with a computer model cardiac simulator.
Read more
To aid surgeons in envisioning different surgical approaches for each individual patient.
To bolster the standard of care surgical planning discussions which will be particularly useful for patients with unique, complex congenital heart disease.
Participants will:
Consent to being randomized with a 50% chance of receiving standard of care "on the fly" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of the computer software cardiac simulator.
Receive results of their computer simulated findings during their surgical planning discussion if they are in the cardiac simulator group.
Read the detailed description
The computer software will be developed at the Cardiovascular Biomechanics Computation Lab at Stanford.
- Conditions
- Congenital Heart Disease in Children
- Being tested
- Cardiac simulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac simulatorDevice
A computer software cardiac simulator for surgical planning in complex Congenital Heart Disease (CHD) pediatric patients.
| Study group | Role | What they receive |
|---|---|---|
| Conventional surgical planning discussion without cardiac simulator | No intervention | Conventional surgical planning discussion without cardiac simulator |
| Surgical planning discussion with aid of cardiac simulator | Experimental | Surgical planning discussion with aid of cardiac simulator Receives: Device: Cardiac simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Alive or deceased post-operative
Measured: At date of hospital discharge or up to 30 days post-operation
Secondary outcomes (2)
Mortality
Alive or deceased long-term
Measured: Latest follow-up exam up to 3 years post-operation
Number of cardioplegic arrest
Due to quality of pathways to blood flow, function of inlet and outlet valves, or residual hemodynamic lesions during operation (up to 5 times)
Measured: Up to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study startApr 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization to either receive standard of care "on the fly" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of computer simulation.
- Masking
- None (open label)
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Principal investigator, Alison Lesley Marsden, Stanford University
- Investigators
- Alison Marsden, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373705
- Sponsor's protocol ID
- 74566
- Other IDs
- 1R01HL173845-01
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing a Multi-Physics Cardiac Simulator for Surgical Planning in Complex Congenital Heart Disease Pediatric Patients
- ClinicalTrials.gov ID
- NCT06373705
- Acronym / sponsor ID
- 74566
- Conditions
- Congenital Heart Disease in Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if a computer software program (cardiac simulator) for surgical planning will lead to improvements in patient care by decreasing the incidence of unsuccessful interventions and reinterventions for pediatric patients with congenital heart disease. It is not a commercially available device to treat congenital heart disease in pediatric patients. The main aims are:
To provide safe pre-operative testing of surgical approaches with a computer model cardiac simulator.
To aid surgeons in envisioning different surgical approaches for each individual patient.
To bolster the standard of care surgical planning discussions which will be particularly useful for patients with unique, complex congenital heart disease.
Participants will:
Consent to being randomized with a 50% chance of receiving standard of care "on the fly" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of the computer software cardiac simulator.
Receive results of their computer simulated findings during their surgical planning discussion if they are in the cardiac simulator group.
Detailed description
The computer software will be developed at the Cardiovascular Biomechanics Computation Lab at Stanford.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization to either receive standard of care "on the fly" surgical planning discussion as is current practice or assisted surgical planning discussion with the aid of computer simulation.
| Arm | Type | Receives |
|---|---|---|
| Conventional surgical planning discussion without cardiac simulator | No intervention | –Conventional surgical planning discussion without cardiac simulator |
| Surgical planning discussion with aid of cardiac simulator | Experimental | Device: Cardiac simulatorSurgical planning discussion with aid of cardiac simulator |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The inclusion criteria are pediatric patients ages 0-17 with a congenital heart disease (CHD) diagnosis of 1) congenitally corrected transposition of the great arteries (cc-TGA) with ventricular septal defect (VSD), 2) double outlet right ventricle (DORV) with remote VSD, or 3) other single ventricle conditions.
Key exclusion criteria (1 listed)
- Adult patients with CHD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac simulatorA computer software cardiac simulator for surgical planning in complex Congenital Heart Disease (CHD) pediatric patients. | Device | Surgical planning discussion with aid of cardiac simulator |
Primary outcome
Mortality
Time frame: At date of hospital discharge or up to 30 days post-operation
Alive or deceased post-operative
2 secondary outcomes
Mortality
Time frame: Latest follow-up exam up to 3 years post-operation
Number of cardioplegic arrest
Time frame: Up to 10 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alison Marsden, PhD principal investigator
Stanford University
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac simulator in people with Congenital Heart Disease in Children, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: At date of hospital discharge or up to 30 days post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.